Genzyme Announces Successful Completion of Study Investigating Sevelamer Carbonate in Patients with Chronic Kidney Disease
Genzyme Corp. announced that a recently completed study of Renvela(TM) (sevelamer carbonate) achieved its primary endpoint, demonstrating a statistically significant reduction in serum phosphorus for hyperphosphatemic patients with chronic kidney disease who are not on dialysis.
Patients treated with Renvela also achieved a significant reduction in calcium-phosphorus product and in LDL cholesterol. The drug was well tolerated with a safety profile consistent with the clinical experience of patients on dialysis using Renagel® (sevelamer hydrochloride). The multi-center, single arm, open-label trial involved 49 patients at multiple study sites throughout Europe and Australia.
Renvela is a buffered form of Renagel. Like Renagel, Renvela is a calcium-free, metal-free, non-absorbed phosphate binder. A New Drug Application for Renvela is currently under review by the US Food and Drug Administration for the control of serum phosphorus in patients with chronic kidney disease on dialysis.
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